Letter to FDA Demanding Explanation for Dangerous Delay Between Identifying Problems and Public Recall of Potentially Contaminated Products Distributed by Balanced Solutions Compounding Pharmacy
April 22, 2013
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Public Citizen requests an explanation for the unacceptable one-month delay between the Food and Drug Administration’s (FDA’s) inspection of Axium Healthcare Pharmacy (dba Balanced Solutions Compounding Pharmacy), which was finished on March 15, 2013 and identified serious quality control problems related to the production of sterile drugs, and the subsequent nationwide voluntary recall of all lots of sterile products compounded by this pharmacy on April 17, 2013.
September 2013 Response from FDA